Sifting Through Chaos: Applying a Quality by Design Approach to Data Governance

  • Why applying a Quality by Design approach to data governance is needed to prevent the high costs of data sprawl
  • How data governance ensures Data is FAIR and meets ALCOA++ requirements to ensure data integrity and reliability
  • The components of a comprehensive data governance framework, including data definition, discovery, remediation, reporting, alerting, and retirements
  • How to implement a phased approach to transition from data chaos to control

Panel Discussion: Optimizing patient recruitment strategies

  • Selecting recruitment partners and collaborating with advocacy groups, patient organizations and care givers to extend patient reach
  • Communicating effectively and working together with sites to assist in recruitment
  • Complying with regulation across differing therapeutic areas
  • Finding innovative solutions to reduce patient burden

What’s Your Real Problem? Reframing the Core Challenges of Global Trials

  • Consider the best problem to solve isn’t the most “obvious” problem.
  • Rethink vendor oversight as a shared-risk partnership problem, not a monitoring problem
  • Design resilience into trial delivery through problem anticipation, not reaction
  • Reframe “inspection readiness” as solving for trust and transparency, not just checklist compliance

Navigating a changing and uncertain regulatory landscape

  • Sharing tips for dealing with regulatory uncertainty whilst keeping your trial on track
  • Complying with FDA data requirements
  • Managing funding cuts and changing tariffs
  • Keeping abreast of updated guidelines and policy shifts

Improving efficiency and quality of clinical trials with support of multi agent AI systems

  • Highlighting the fast-evolving development of multi-agent AI tools available
  • Using humanoid robots to carry out motion-based tasks in the laboratory and the workplace
  • Understanding how multi-agentic systems can support and improve different phases, operations, and processes of clinical trials
  • Improving the design, enrolment, execution, analysis, results, and reporting in clinical trials with multi-agent systems